186 resultados para randomized controlled trial


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BACKGROUND: Intradialytic exercise programmes are important because of the deterioration in physical function that occurs in people receiving haemodialysis. Unfortunately, exercise programmes are rarely sustained in haemodialysis clinics. The aim of this study was to determine the efficacy of a sustainable resistance exercise programme on the physical function of people receiving haemodialysis. METHODS: A total of 171 participants from 15 community satellite haemodialysis clinics performed progressive resistance training using resistance elastic bands in a seated position during the first hour of haemodialysis treatment. We used a stepped-wedge design of three groups, each containing five randomly allocated cluster units allocated to an intervention of 12, 24 or 36 weeks. The primary outcome measure was objective physical function measured by the 30-s sit-to-stand (STS) test, the 8-foot timed up and go (TUG) test and the four-square step test. Secondary outcome measures included quality of life, involvement in community activity, blood pressure and self-reported falls. RESULTS: Exercise training led to significant improvements in physical function as measured by STS and TUG. There was a significant average downward change (β = -1.59, P < 0.01) before the intervention and a significant upward change after the intervention (β = 0.38, P < 0.01) for the 30-s STS with a similar pattern noted for the TUG. CONCLUSION: Intradialytic resistance training can improve the physical function of people receiving dialysis.

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OBJECTIVES: Educator-led programs for physical activity and motor skill development show potential but few have been implemented and evaluated using a randomized controlled design. Furthermore, few educator-led programs have evaluated both gross motor skills and physical activity. Therefore, the aim of this study was to evaluate a gross motor skill and physical activity program for preschool children which was facilitated solely by childcare educators. DESIGN: A six-month 2-arm randomized controlled trial was implemented between April and September 2012 in four early childhood centers in Tasmania, Australia. METHODS: Educators participated in ongoing professional development sessions and children participated in structured physical activity lessons and unstructured physical activity sessions. RESULTS: In total, 150 children were recruited from four centers which were randomized to intervention or wait-list control group. Six early childhood educators from the intervention centers were trained to deliver the intervention. Gross motor skills were assessed using the Test of Gross Motor Development (2nd edition) and physical activity was measured objectively using GT3X+ Actigraph accelerometers. No statistically significant differences were identified. However, small to medium effect sizes, in favor of the intervention group, were evident for four of the five gross motor skills and the total gross motor skill score and small to medium effect sizes were reported for all physical activity outcomes. CONCLUSIONS: This study highlights the potential of educator-led physical activity interventions and supports the need for further translational trials within the early childhood sector.

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AIM: To determine the effectiveness and cost-effectiveness of a mobile phone intervention to improve exercise capacity and physical activity behaviour in people with ischaemic heart disease (IHD).

METHODS AND RESULTS: In this single-blind, parallel, two-arm, randomized controlled trial adults (n = 171) with IHD were randomized to receive a mobile phone delivered intervention (HEART; n = 85) plus usual care, or usual care alone (n = 86). Adult participants aged 18 years or more, with a diagnosis of IHD, were clinically stable as outpatients, able to perform exercise, able to understand and write English, and had access to the Internet. The HEART (Heart Exercise And Remote Technologies) intervention involved a personalized, automated package of text messages and a secure website with video messages aimed at increasing exercise behaviour, delivered over 24 weeks. All participants were able to access usual community-based cardiac rehabilitation, which involves encouragement of physical activity and an offer to join a local cardiac support club. All outcomes were assessed at baseline and 24 weeks and included peak oxygen uptake (PVO2; primary outcome), self-reported physical activity, health-related quality of life, self-efficacy and motivation (secondary outcomes). Results showed no differences in PVO2 between the two groups (difference -0.21 ml kg(-1)min(-1), 95% CI: -1.1, 0.7; p = 0.65) at 24 weeks. However significant treatment effects were observed for selected secondary outcomes, including leisure time physical activity (difference 110.2 min/week, 95% CI: -0.8, 221.3; p = 0.05) and walking (difference 151.4 min/week, 95% CI: 27.6, 275.2; p = 0.02). There were also significant improvements in self-efficacy to be active (difference 6.2%, 95% CI: 0.2, 12.2; p = 0.04) and the general health domain of the SF36 (difference 2.1, 95% CI: 0.1, 4.1; p = 0.03) at 24 weeks. The HEART programme was considered likely to be cost-effective for leisure time activity and walking.

CONCLUSIONS: A mobile phone intervention was not effective at increasing exercise capacity over and above usual care. The intervention was effective and probably cost-effective for increasing physical activity and may have the potential to augment existing cardiac rehabilitation services.

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BACKGROUND: Given the global prevalence of insufficient physical activity (PA), effective interventions that attenuate age-related decline in PA levels are needed. Mobile phone interventions that positively affect health (mHealth) show promise; however, their impact on PA levels and fitness in young people is unclear and little is known about what makes a good mHealth app. OBJECTIVE: The aim was to determine the effects of two commercially available smartphone apps (Zombies, Run and Get Running) on cardiorespiratory fitness and PA levels in insufficiently active healthy young people. A second aim was to identify the features of the app design that may contribute to improved fitness and PA levels. METHODS: Apps for IMproving FITness (AIMFIT) was a 3-arm, parallel, randomized controlled trial conducted in Auckland, New Zealand. Participants were recruited through advertisements in electronic mailing lists, local newspapers, flyers posted in community locations, and presentations at schools. Eligible young people aged 14-17 years were allocated at random to 1 of 3 conditions: (1) use of an immersive app (Zombies, Run), (2) use of a nonimmersive app (Get Running), or (3) usual behavior (control). Both smartphone apps consisted of a fully automated 8-week training program designed to improve fitness and ability to run 5 km; however, the immersive app featured a game-themed design and narrative. Intention-to-treat analysis was performed using data collected face-to-face at baseline and 8 weeks, and all regression models were adjusted for baseline outcome value and gender. The primary outcome was cardiorespiratory fitness, objectively assessed as time to complete the 1-mile run/walk test at 8 weeks. Secondary outcomes were PA levels (accelerometry and self-reported), enjoyment, psychological need satisfaction, self-efficacy, and acceptability and usability of the apps. RESULTS: A total of 51 participants were randomized to the immersive app intervention (n=17), nonimmersive app intervention (n=16), or the control group (n=18). The mean age of participants was 15.7 (SD 1.2) years; participants were mostly NZ Europeans (61%, 31/51) and 57% (29/51) were female. Overall retention rate was 96% (49/51). There was no significant intervention effect on the primary outcome using either of the apps. Compared to the control, time to complete the fitness test was -28.4 seconds shorter (95% CI -66.5 to 9.82, P=.20) for the immersive app group and -24.7 seconds (95% CI -63.5 to 14.2, P=.32) for the nonimmersive app group. No significant intervention effects were found for secondary outcomes. CONCLUSIONS: Although apps have the ability to increase reach at a low cost, our pragmatic approach using readily available commercial apps as a stand-alone instrument did not have a significant effect on fitness. However, interest in future use of PA apps is promising and highlights a potentially important role of these tools in a multifaceted approach to increase fitness, promote PA, and consequently reduce the adverse health outcomes associated with insufficient activity.

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BACKGROUND: Mobile technology has the potential to deliver behavior change interventions (mHealth) to reduce coronary heart disease (CHD) at modest cost. Previous studies have focused on single behaviors; however, cardiac rehabilitation (CR), a component of CHD self-management, needs to address multiple risk factors. OBJECTIVE: The aim was to investigate the effectiveness of a mHealth-delivered comprehensive CR program (Text4Heart) to improve adherence to recommended lifestyle behaviors (smoking cessation, physical activity, healthy diet, and nonharmful alcohol use) in addition to usual care (traditional CR). METHODS: A 2-arm, parallel, randomized controlled trial was conducted in New Zealand adults diagnosed with CHD. Participants were recruited in-hospital and were encouraged to attend center-based CR (usual care control). In addition, the intervention group received a personalized 24-week mHealth program, framed in social cognitive theory, sent by fully automated daily short message service (SMS) text messages and a supporting website. The primary outcome was adherence to healthy lifestyle behaviors measured using a self-reported composite health behavior score (≥3) at 3 and 6 months. Secondary outcomes included clinical outcomes, medication adherence score, self-efficacy, illness perceptions, and anxiety and/or depression at 6 months. Baseline and 6-month follow-up assessments (unblinded) were conducted in person. RESULTS: Eligible patients (N=123) recruited from 2 large metropolitan hospitals were randomized to the intervention (n=61) or the control (n=62) group. Participants were predominantly male (100/123, 81.3%), New Zealand European (73/123, 59.3%), with a mean age of 59.5 (SD 11.1) years. A significant treatment effect in favor of the intervention was observed for the primary outcome at 3 months (AOR 2.55, 95% CI 1.12-5.84; P=.03), but not at 6 months (AOR 1.93, 95% CI 0.83-4.53; P=.13). The intervention group reported significantly greater medication adherence score (mean difference: 0.58, 95% CI 0.19-0.97; P=.004). The majority of intervention participants reported reading all their text messages (52/61, 85%). The number of visits to the website per person ranged from zero to 100 (median 3) over the 6-month intervention period. CONCLUSIONS: A mHealth CR intervention plus usual care showed a positive effect on adherence to multiple lifestyle behavior changes at 3 months in New Zealand adults with CHD compared to usual care alone. The effect was not sustained to the end of the 6-month intervention. A larger study is needed to determine the size of the effect in the longer term and whether the change in behavior reduces adverse cardiovascular events. TRIAL REGISTRATION: ACTRN 12613000901707; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=364758&isReview=true (Archived by WebCite at http://www.webcitation.org/6c4qhcHKt).

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BACKGROUND: Screen-based activities, such as watching television (TV), playing video games, and using computers, are common sedentary behaviors among young people and have been linked with increased energy intake and overweight. Previous home-based sedentary behaviour interventions have been limited by focusing primarily on the child, small sample sizes, and short follow-up periods. The SWITCH (Screen-Time Weight-loss Intervention Targeting Children at Home) study aimed to determine the effect of a home-based, family-delivered intervention to reduce screen-based sedentary behaviour on body composition, sedentary behaviour, physical activity, and diet over 24 weeks in overweight and obese children.

METHODS: A two-arm, parallel, randomized controlled trial was conducted. Children and their primary caregiver living in Auckland, New Zealand were recruited via schools, community centres, and word of mouth. The intervention, delivered over 20 weeks, consisted of a face-to-face meeting with the parent/caregiver and the child to deliver intervention content, which focused on training and educating them to use a wide range of strategies designed to reduce their child's screen time. Families were given Time Machine TV monitoring devices to assist with allocating screen time, activity packages to promote alternative activities, online support via a website, and monthly newsletters. Control participants were given the intervention material on completion of follow-up. The primary outcome was change in children's BMI z-score from baseline to 24 weeks.

RESULTS: Children (n = 251) aged 9-12 years and their primary caregiver were randomized to receive the SWITCH intervention (n = 127) or no intervention (controls; n = 124). There was no significant difference in change of zBMI between the intervention and control groups, although a favorable trend was observed (-0.016; 95% CI: -0.084, 0.051; p = 0.64). There were also no significant differences on secondary outcomes, except for a trend towards increased children's moderate intensity physical activity in the intervention group (24.3 min/d; 95% CI: -0.94, 49.51; p = 0.06).

CONCLUSIONS: A home-based, family-delivered intervention to reduce all leisure-time screen use had no significant effect on screen-time or on BMI at 24 weeks in overweight and obese children aged 9-12 years.

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BACKGROUND: Advances in technology allowed the development of a novel smoking cessation program delivered by video messages sent to mobile phones. This social cognitive theory-based intervention (called "STUB IT") used observational learning via short video diary messages from role models going through the quitting process to teach behavioral change techniques.

OBJECTIVE: The objective of our study was to assess the effectiveness of a multimedia mobile phone intervention for smoking cessation.

METHODS: A randomized controlled trial was conducted with 6-month follow-up. Participants had to be 16 years of age or over, be current daily smokers, be ready to quit, and have a video message-capable phone. Recruitment targeted younger adults predominantly through radio and online advertising. Registration and data collection were completed online, prompted by text messages. The intervention group received an automated package of video and text messages over 6 months that was tailored to self-selected quit date, role model, and timing of messages. Extra messages were available on demand to beat cravings and address lapses. The control group also set a quit date and received a general health video message sent to their phone every 2 weeks.

RESULTS: The target sample size was not achieved due to difficulty recruiting young adult quitters. Of the 226 randomized participants, 47% (107/226) were female and 24% (54/226) were Maori (indigenous population of New Zealand). Their mean age was 27 years (SD 8.7), and there was a high level of nicotine addiction. Continuous abstinence at 6 months was 26.4% (29/110) in the intervention group and 27.6% (32/116) in the control group (P = .8). Feedback from participants indicated that the support provided by the video role models was important and appreciated.

CONCLUSIONS: This study was not able to demonstrate a statistically significant effect of the complex video messaging mobile phone intervention compared with simple general health video messages via mobile phone. However, there was sufficient positive feedback about the ease of use of this novel intervention, and the support obtained by observing the role model video messages, to warrant further investigation.

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BACKGROUND: Sedentary activities such as video gaming are independently associated with obesity. Active video games, in which players physically interact with images on screen, may help increase physical activity and improve body composition.

OBJECTIVE: The aim of this study was to evaluate the effect of active video games over a 6-mo period on weight, body composition, physical activity, and physical fitness.

DESIGN: We conducted a 2-arm, parallel, randomized controlled trial in Auckland, New Zealand. A total of 322 overweight and obese children aged 10-14 y, who were current users of sedentary video games, were randomly assigned at a 1:1 ratio to receive either an active video game upgrade package (intervention, n = 160) or to have no change (control group, n = 162). The primary outcome was the change from baseline in body mass index (BMI; in kg/m(2)). Secondary outcomes were changes in percentage body fat, physical activity, cardiorespiratory fitness, video game play, and food snacking.

RESULTS: At 24 wk, the treatment effect on BMI (-0.24; 95% CI: -0.44, -0.05; P = 0.02) favored the intervention group. The change (±SE) in BMI from baseline increased in the control group (0.34 ± 0.08) but remained the same in the intervention group (0.09 ± 0.08). There was also evidence of a reduction in body fat in the intervention group (-0.83%; 95% CI: -1.54%, -0.12%; P = 0.02). The change in daily time spent playing active video games at 24 wk increased (10.03 min; 95% CI: 6.26, 13.81 min; P < 0.0001) with the intervention accompanied by a reduction in the change in daily time spent playing nonactive video games (-9.39 min; 95% CI: -19.38, 0.59 min; P = 0.06).

CONCLUSION: An active video game intervention has a small but definite effect on BMI and body composition in overweight and obese children.

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BACKGROUND: Approximately one third of New Zealand children and young people are overweight or obese. A similar proportion (33%) do not meet recommendations for physical activity, and 70% do not meet recommendations for screen time. Increased time being sedentary is positively associated with being overweight. There are few family-based interventions aimed at reducing sedentary behavior in children. The aim of this trial is to determine the effects of a 24 week home-based, family oriented intervention to reduce sedentary screen time on children's body composition, sedentary behavior, physical activity, and diet.

METHODS/DESIGN: The study design is a pragmatic two-arm parallel randomized controlled trial. Two hundred and seventy overweight children aged 9-12 years and primary caregivers are being recruited. Participants are randomized to intervention (family-based screen time intervention) or control (no change). At the end of the study, the control group is offered the intervention content. Data collection is undertaken at baseline and 24 weeks. The primary trial outcome is child body mass index (BMI) and standardized body mass index (zBMI). Secondary outcomes are change from baseline to 24 weeks in child percentage body fat; waist circumference; self-reported average daily time spent in physical and sedentary activities; dietary intake; and enjoyment of physical activity and sedentary behavior. Secondary outcomes for the primary caregiver include change in BMI and self-reported physical activity.

DISCUSSION: This study provides an excellent example of a theory-based, pragmatic, community-based trial targeting sedentary behavior in overweight children. The study has been specifically designed to allow for estimation of the consistency of effects on body composition for Māori (indigenous), Pacific and non-Māori/non-Pacific ethnic groups. If effective, this intervention is imminently scalable and could be integrated within existing weight management programs..

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Background: Most smokers want to stop smoking and many try to quit. However abstinence rates are low and most smokers do not manage to abstain for even a week. Relapse to smoking can be related to the occurrence of tobacco withdrawal symptoms (e.g., sleep disturbance, irritability, and craving) and weight gain. If regular exercise mitigates these effects it could have potential as an aid to smoking cessation. The aim of the Fit2Quit study is to determine the effects of a home and community-based exercise intervention on smoking abstinence at six months when used as an adjunct to usual care (telephone smoking-cessation counseling and nicotine replacement therapy; NRT). Methods/design: A prospective parallel two-arm randomized controlled trial. Participants (n = 1400, 700 per arm) will be randomized to a structured home and community-based exercise program plus usual care (behavioral counseling and NRT) or to usual-care alone. It is targeted that at least 25% of the sample will be of Mori ethnicity (New Zealand indigenous). Outcomes to be measured using intention-to-treat analysis include: seven-day point prevalence of smoking abstinence verified by salivary cotinine (primary outcome); 6 months continuous abstinence; body mass index (BMI); cardio-respiratory fitness; physical activity levels; and cost effectiveness. Discussion: The Fit2Quit study is an example of a large, pragmatic randomized controlled trial in a community setting. Specific components of the exercise intervention are outlined in detail. Trial registration: Australian New Zealand Clinical Trials Registry ACTRN12609000637246.

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BACKGROUND: Childhood obesity has reached epidemic proportions in developed countries. Sedentary screen-based activities such as video gaming are thought to displace active behaviors and are independently associated with obesity. Active video games, where players physically interact with images onscreen, may have utility as a novel intervention to increase physical activity and improve body composition in children. The aim of the Electronic Games to Aid Motivation to Exercise (eGAME) study is to determine the effects of an active video game intervention over 6 months on: body mass index (BMI), percent body fat, waist circumference, cardio-respiratory fitness, and physical activity levels in overweight children.

METHODS/DESIGN: Three hundred and thirty participants aged 10-14 years will be randomized to receive either an active video game upgrade package or to a control group (no intervention).

DISCUSSION: An overview of the eGAME study is presented, providing an example of a large, pragmatic randomized controlled trial in a community setting. Reflection is offered on key issues encountered during the course of the study. In particular, investigation into the feasibility of the proposed intervention, as well as robust testing of proposed study procedures is a critical step prior to implementation of a large-scale trial.

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Background: There is evidence that physical activity (PA) can attenuate the influence of the fat mass- and obesity-associated (FTO) genotype on the risk to develop obesity. However, whether providing personalized information on FTO genotype leads to changes in PA is unknown. Objective: The purpose of this study was to determine if disclosing FTO risk had an impact on change in PA following a 6-month intervention.

Methods: The single nucleotide polymorphism (SNP) rs9939609 in the FTO gene was genotyped in 1279 participants of the Food4Me study, a four-arm, Web-based randomized controlled trial (RCT) in 7 European countries on the effects of personalized advice on nutrition and PA. PA was measured objectively using a TracmorD accelerometer and was self-reported using the Baecke questionnaire at baseline and 6 months. Differences in baseline PA variables between risk (AA and AT genotypes) and nonrisk (TT genotype) carriers were tested using multiple linear regression. Impact of FTO risk disclosure on PA change at 6 months was assessed among participants with inadequate PA, by including an interaction term in the model: disclosure (yes/no) × FTO risk (yes/no).

Results: At baseline, data on PA were available for 874 and 405 participants with the risk and nonrisk FTO genotypes, respectively. There were no significant differences in objectively measured or self-reported baseline PA between risk and nonrisk carriers. A total of 807 (72.05%) of the participants out of 1120 in the personalized groups were encouraged to increase PA at baseline. Knowledge of FTO risk had no impact on PA in either risk or nonrisk carriers after the 6-month intervention. Attrition was higher in nonrisk participants for whom genotype was disclosed (P=.01) compared with their at-risk counterparts.

Conclusions: No association between baseline PA and FTO risk genotype was observed. There was no added benefit of disclosing FTO risk on changes in PA in this personalized intervention. Further RCT studies are warranted to confirm whether disclosure of nonrisk genetic test results has adverse effects on engagement in behavior change.

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BACKGROUND: School-based physical education is an important public health initiative as it has the potential to provide students with regular opportunities to participate in moderate-to-vigorous physical activity (MVPA). Unfortunately, in many physical education lessons students do not engage in sufficient MVPA to achieve health benefits. In this trial we will test the efficacy of a teacher professional development intervention, delivered partially via the Internet, on secondary school students' MVPA during physical education lessons. Teaching strategies covered in this training are designed to (i) maximize opportunities for students to be physically active during lessons and (ii) enhance students' autonomous motivation towards physical activity. METHOD: A two-arm cluster randomized controlled trial with allocation at the school level (intervention vs. usual care control). Teachers and Year 8 students in government-funded secondary schools in low socio-economic areas of the Western Sydney region of Australia will be eligible to participate. During the main portion of the intervention (6 months), teachers will participate in two workshops and complete two implementation tasks at their school. Implementation tasks will involve video-based self-reflection via the project's Web 2.0 platform and an individualized feedback meeting with a project mentor. Each intervention school will also complete two group peer-mentoring sessions at their school (one per term) in which they will discuss implementation with members of their school physical education staff. In the booster period (3 months), teachers will complete a half-day workshop at their school, plus one online implementation task, and a group mentoring session at their school. Throughout the entire intervention period (main intervention plus booster period), teachers will have access to online resources. Data collection will include baseline, post-intervention (7-8 months after baseline) and maintenance phase (14-15 months after baseline) assessments. Research assistants blinded to group allocation will collect all data. The primary outcome will be the proportion of physical education lesson time that students spend in MVPA. Secondary outcomes will include leisure-time physical activity, subjective well-being, and motivation towards physical activity.
DISCUSSION: The provision of an online training platform for teachers could help facilitate more widespread dissemination of evidence-based interventions compared with programs that rely exclusively on face-to-face training.

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OBJECTIVE: Pricing strategies are a promising approach for promoting healthier dietary choices. However, robust evidence of the cost-effectiveness of pricing manipulations on dietary behaviour is limited. We aimed to assess the cost-effectiveness of a 20% price reduction on fruits and vegetables and a combined skills-based behaviour change and price reduction intervention. DESIGN AND METHODS: Cost-effectiveness analysis from a societal perspective was undertaken for the randomized controlled trial Supermarket Healthy Eating for Life (SHELf). Female shoppers in Melbourne, Australia were randomized to: (1) skill-building (n = 160); (2) price reductions (n = 161); (3) combined skill-building and price reduction (n = 161); or (4) control group (n = 161). The intervention was implemented for three months followed by a six month follow-up. Costs were measured in 2012 Australian dollars. Fruit and vegetable purchasing and consumption were measured in grams/week. RESULTS: At three months, compared to control participants, price reduction participants increased vegetable purchases by 233 g/week (95% CI 4 to 462, p = 0.046) and fruit purchases by 364 g/week (95% CI 95 to 633, p = 0.008). Participants in the combined group purchased 280 g/week more fruits (95% CI 27 to 533, p = 0.03) than participants in the control group. Increases were not maintained six-month post intervention. No effect was noticed in the skill-building group. Compared to the control group, the price reduction intervention cost an additional A$2.3 per increased serving of vegetables purchased per week or an additional A$3 per increased serving of fruit purchased per week. The combined intervention cost an additional A$12 per increased serving of fruit purchased per week compared to the control group. CONCLUSIONS: A 20% discount on fruits and vegetables was effective in promoting overall fruit and vegetable purchases during the period the discount was active and may be cost-effective. The price discount program gave better value for money than the combined price reduction and skill-building intervention. The SHELf trial is registered with Current Controlled Trials Registration ISRCTN39432901.